Acetaminophen and Propoxyphene will no longer be available in the U.S. after November 19, 2010. If you are currently using propoxyphene, you should call your doctor to discuss switching to another treatment.

[Posted 01/13/2011]ISSUE:FDA notified healthcare professionals that it has asked drug manufacturers to limit the strength of acetaminophen in prescription drug products, predominantly combinations of acetaminophen and opioids, to 325 mg per tablet, capsule, or other dosage unit, making these products safer for patients. This action will help to reduce the risk of severe liver injury and allergic reactions associated with acetaminophen. A Boxed Warning highlighting the potential for severe liver injury and a Warning highlighting the potential for allergic reactions (swelling of the face, mouth, and throat, difficulty breathing, itching, or rash) will be added to the label of all prescription drug products that contain acetaminophen.

BACKGROUND:Acetaminophen, one of the most commonly used drugs in the United States, is widely and effectively used in both prescription and over-the-counter (OTC) products to reduce pain and fever. Examples of prescription products that contain acetaminophen include hydrocodone with acetaminophen (Vicodin, Lortab), and oxycodone with acetaminophen (Tylox, Percocet). OTC products containing acetaminophen (e.g., Tylenol) are not affected by this action. Information about the potential for liver injury is already required on the label for OTC products containing acetaminophen. FDA is continuing to evaluate ways to reduce the risk of acetaminophen related liver injury from OTC products. No drug shortages are expected, because the 3-year implementation period should permit adequate time for necessary reformulations.

RECOMMENDATION:Healthcare professionals were reminded to advise patients not to exceed the acetaminophen maximum total daily dose (4 grams/day), and not to drink alcohol while taking acetaminophen-containing medications.

Healthcare professionals were encouraged to inform patients that there is no immediate danger to patients who take these combination pain medications, and patients should continue to take them as directed by their health care provider. The Drug Safety Communication provides additional information for healthcare professionals, information for patients, a data summary and a list of all affected products. For more information visit the FDA website at: Web Siteand Web Site.

[Posted 11/19/2010]ISSUE:FDA notified healthcare professionals that Xanodyne Pharmaceuticals has agreed to withdraw propoxyphene (Darvon), an opioid pain reliever used to treat mild to moderate pain, from the U.S. market at the request of the FDA, due to new data showing that the drug can cause serious toxicity to the heart, even when used at therapeutic doses. FDA concluded that the safety risks of propoxyphene outweigh its benefits for pain relief at recommended doses. FDA requested that the generic manufacturers of propoxyphene-containing products [e.g., propoxyphene combined with acetaminophen (Darvocet)] remove their products as well.

BACKGROUND:FDA's recommendation is based on all available data including data from a new study that evaluated the effects that increasing doses of propoxyphene have on the heart (see Data Summary in Drug Safety Communication). The results of the new study showed that when propoxyphene was taken at therapeutic doses, there were significant changes to the electrical activity of the heart: prolonged PR interval, widened QRS complex and prolonged QT interval. These changes can increase the risk for serious abnormal heart rhythms.

RECOMMENDATION:FDA recommends that healthcare professionals stop prescribing and dispensing propoxyphene-containing products to patients, contact patients currently taking propoxyphene-containing products and ask them to discontinue the drug, inform patients of the risks associated with propoxyphene, and discuss alternative pain management strategies. Patients were advised to dispose of unused propoxyphene in household trash by following the recommendations outlined in the Federal Drug Disposal Guidelines at: Web Site. For more information visit the FDA website at: Web Siteand Web Site.

[Posted 7/7/2009] FDA notified healthcare professionals that it is taking several actions to reduce the risk of overdose in patients using pain medications that contain propoxyphene because of data linking propoxyphene and fatal overdoses. The agency will require manufacturers of propoxyphene-containing products to strengthen the label, including the boxed warning, emphasizing the potential for overdose when using these products and to provide a medication guide to patients stressing the importance of using the drugs as directed.

FDA is requiring a new safety study assessing unanswered questions about the effects of propoxyphene on the heart at higher than recommended doses. Findings from this study, as well as other data, could lead to additional regulatory action. To further evaluate the safety of propoxyphene, FDA plans to work with several groups including the Centers for Medicare & Medicaid Services and the Veterans Health Administration to study how often the elderly are prescribed propoxyphene instead of other pain relievers and the difference in the safety profiles of propoxyphene compared to other drugs. For more information visit the FDA website at: Web Siteand Web Site.

IMPORTANT WARNING

Propoxyphene in high doses, taken by itself or in combination with other drugs, has been associated with drug-related deaths. Do not take propoxyphene in combination with other drugs that cause drowsiness: alcohol, tranquilizers, sleep aids, antidepressant drugs, or antihistamines. Do not take a larger dose, take it more often, or for a longer period than your doctor tells you to.

WHY is this medicine prescribed?

This combination of drugs is used to relieve mild to moderate pain. The drug also will help treat fever.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

The combination of acetaminophen and propoxyphene comes as a tablet to take by mouth. It usually is taken every 4 hours as needed. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take acetaminophen and propoxyphene exactly as directed.

Propoxyphene can be habit-forming. Do not take a larger dose, take it more often, or for a longer period than your doctor tells you to.

What SPECIAL PRECAUTIONS should I follow?

Before taking acetaminophen and propoxyphene,

tell your doctor and pharmacist if you are allergic to acetaminophen, propoxyphene, sulfite, or any other drugs.

tell your doctor if you have or have ever had liver or kidney disease, a history of alcoholism, lung or thyroid disease, prostatic hypertrophy, or urinary retention.

tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking acetaminophen and propoxyphene, call your doctor.

if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking acetaminophen and propoxyphene.

you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you.

remember that alcohol can add to the drowsiness caused by this drug.

What should I do IF I FORGET to take a dose?

This medication usually is taken as needed. If your doctor has told you to take acetaminophen and propoxyphene regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Acetaminophen and propoxyphene may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

dizziness

lightheadedness

drowsiness

upset stomach

vomiting

constipation

stomach pain

rash

difficulty urinating

If you experience either of the following symptoms, call your doctor immediately:

difficulty breathing

mood changes

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at Web Site] or by phone [1-800-332-1088].

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

What should I do in case of OVERDOSE?

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Too much acetaminophen may cause liver damage; do not take more than 4000 mg of acetaminophen per day.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

¶This branded product is no longer on the market. Generic alternatives may be available.

Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.